AqueousJoint is a new intra-articular (IA) injectable joint lubricant for patients suffering from knee Osteoarthritis developed by Liposphere LTD. AqueousJoint is a liposomal boundary lubricant, which coats the cartilage surface and protects it from further damage and degradation. The product goal is restoring cartilage its natural bio-lubrication properties. AqueousJoint is a surface lubricant that does not change the synovial fluid mechanical characterization but provides hydration protection from cartilage degradation and wear.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
AqueousJoint is a liposomal boundary lubricant, which coats the cartilage surface and protects it from further damage and degradation.
Assuta
Ashdod, Israel
Adverse Events will be evaluated in order to assess the safety of intra-articular injection of Aqueous Joint in osteoarthritic patients up to 26 weeks of follow-up in an open-label clinical study.
The safety parameters will include adverse reactions related to the injected material; injection-related side effects consisted of injection-site reaction, erythema, swelling, injection-site pain, and pruritus.
Time frame: 26 weeks
Change in range of motion from visit 1 (pre-injection) to week 26
To measure the effectiveness of the treatment on a range of motion by physical examination
Time frame: 26 weeks
Change in life quality from visit 1 (pre-injection) to week 26
To measure the effectiveness of the treatment on life quality by SF12 Questionnaire
Time frame: 26 weeks
Change in functionality from visit 1 (pre-injection) to week 26
To measure the effectiveness of the treatment on functionality using PRO: KOOS and Physical activity test - Timed up and go examination
Time frame: 26 weeks
Change in pain level and analgesics consumption from visit 1 (pre-injection) to week 26
To measure the effectiveness of the treatment on pain level using VAS and concomitant medication log
Time frame: 26 weeks
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